Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

NCT00483574 | Completed Phase 3 Results DMC

• 1 other identifier: MTA48
• Study Type: interventional
• Target: 1,378
• Locations: 2 countries
• Sites: 79

Brief Summary

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.

Conditions

Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella

Keywords

Menactra® vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.

  Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

  Day 0 to 7 Post-vaccination

Other Outcomes (1)

• Safety Overview After Any Vaccination in Participants Who Received MMR+V

  Day 0 to 7 Post-vaccination

Study Arms (2)

Group 1: Menactra® and Routine Pediatric Vaccines

EXPERIMENTAL

Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months.

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Biological: Measles-mumps-rubella-varicella vaccine; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); Biological: Routine paediatric vaccine - Hepatitis A

Group 2: Routine Pediatric Vaccines

OTHER

Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.

Biological: Measles-mumps-rubella-varicella vaccine; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); Biological: Routine paediatric vaccine - Hepatitis A

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, IM at age 9 and 12 months

Also known as: Menactra®

Group 1: Menactra® and Routine Pediatric Vaccines

Measles-mumps-rubella-varicella vaccine BIOLOGICAL

0.5 mL, intramuscular at 12 months of age

Also known as: MMRV: ProQuad

Group 1: Menactra® and Routine Pediatric Vaccines; Group 2: Routine Pediatric Vaccines

Routine paediatric vaccine - Pneumococcal conjugate (PCV) BIOLOGICAL

0.5 mL, Intramuscular at age 12 months

Also known as: Pneumococcal conjugate (PCV),

Group 1: Menactra® and Routine Pediatric Vaccines; Group 2: Routine Pediatric Vaccines

Routine paediatric vaccine - Hepatitis A BIOLOGICAL

0.5 mL, Intramuscular at age 12 months

Also known as: Hepatitis A

Group 1: Menactra® and Routine Pediatric Vaccines; Group 2: Routine Pediatric Vaccines

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy, as determined by medical history and physical examination
• Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment
• The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.

You may not qualify if:

• Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
• Known or suspected impairment of immunologic function.
• Acute medical illness within the last 72 hours or a temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of enrollment.
• History of documented invasive meningococcal disease or previous meningococcal vaccination.
• Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.
• Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
• Received either immune globulin or other blood products within the last 3 months.
• Suspected or known hypersensitivity to any of the vaccine components.
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
• Parent or legal guardian unable or unwilling to comply with the study procedures.
• Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
• Diagnosed with any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
• Received any vaccine in the 30-day period prior to receipt of the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).
• Personal or family history of Guillain-Barré Syndrome (GBS).
• History of seizures, including febrile seizures, or any other neurologic disorder.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (79)

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Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35244, United States

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Dothan, Alabama, 36305, United States

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Pinson, Alabama, 35126, United States

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Tuscaloosa, Alabama, 35406, United States

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Chandler, Arizona, 85234, United States

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Bentonville, Arkansas, 72712, United States

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Conway, Arkansas, 72034, United States

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Hardy, Arkansas, 72542, United States

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Jonesboro, Arkansas, 72401, United States

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Downy, California, 90241, United States

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Fountain Valley, California, 92708, United States

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Huntington Beach, California, 92647, United States

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Huntington Park, California, 90255, United States

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La Jolla, California, 92037, United States

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LaCosta, California, 92009, United States

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Pico Rivera, California, 90660, United States

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Centennial, Colorado, 80112, United States

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Longmont, Colorado, 80501, United States

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Thornton, Colorado, 80233, United States

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Lake Mary, Florida, 32746, United States

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Tampa, Florida, 33614, United States

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Stone Mountain, Georgia, 30087, United States

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Boise, Idaho, 83704, United States

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Evansville, Indiana, 47710, United States

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Arkansas City, Kansas, 67005, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Louisville, Kentucky, 40272, United States

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Fall River, Massachusetts, 02724, United States

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Clifton, New Jersey, 07013, United States

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Endwell, New York, 13760, United States

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Liverpool, New York, 13088, United States

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Utica, New York, 13502, United States

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Garner, North Carolina, 27529, United States

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Raleigh, North Carolina, 27615, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Minot, North Dakota, 58701, United States

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Cincinnati, Ohio, 45245, United States

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Fairfield, Ohio, 45014, United States

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Huber Heights, Ohio, 45424, United States

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Kettering, Ohio, 45429, United States

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Mason, Ohio, 45040, United States

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Poland, Ohio, 44514, United States

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Youngstown, Ohio, 44505, United States

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Meadowbrook, Pennsylvania, 19046, United States

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Philadelphia, Pennsylvania, 19114, United States

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Philadelphia, Pennsylvania, 19116, United States

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Pittsburgh, Pennsylvania, 15217, United States

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Barrington, Rhode Island, 02806, United States

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Providence, Rhode Island, 02903, United States

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Warwick, Rhode Island, 02886, United States

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Barnwell, South Carolina, 29812, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Watertown, South Dakota, 57201, United States

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Bristol, Tennessee, 37620, United States

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Jackson, Tennessee, 38305, United States

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Tullahoma, Tennessee, 37388, United States

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Amarillo, Texas, 79106, United States

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Amarillo, Texas, 79124, United States

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Carrollton, Texas, 75007, United States

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Fort Worth, Texas, 76012, United States

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Grapevine, Texas, 76057, United States

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Houston, Texas, 77065, United States

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Houston, Texas, 77084, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77479, United States

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Tomball, Texas, 77375, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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West Valley City, Utah, 84120, United States

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Newport News, Virginia, 23606, United States

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Norfolk, Virginia, 23507, United States

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Vienna, Virginia, 22180, United States

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Bellingham, Washington, 98226, United States

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Santiago, Chile

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Related Links

• Related Info

MeSH Terms

Conditions

Meningitis, Meningococcal; Measles; Mumps; Rubella; Chickenpox; Haemophilus Infections

Interventions

Meningococcal Vaccines; measles, mumps, rubella, varicella vaccine; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Viral Vaccines

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 16, 2016
• Results First Posted: July 6, 2011

Record last verified: 2016-04

Locations

US (78); CL (1)